A Study to Develop a Cohort Database and Study Platform in Breast Cancer Survivors Using Multiscale Omics


NCT ID: NCT04999826
Sponsor Protocol Number: 19-005860

About this study

The purpose of this study is to develop a breast cancer survivor (BCS) multiscale omics database that includes a complete fecal metagenome (gut microbiome) and fecal metabolome characterization. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult females enrolled in the Mayo Clinic Biospecimen Resource for Breast Disease (IRB # 1815-04).
  • Current ages 18-75 years.
  • Have a prior diagnosis of stage 0-3 (in situ or invasive) breast cancer (BCS).
  • Have completed active therapy (surgery, radiation, and/or chemotherapy) (8-30  months approximately) prior to provision of the samples).
  • Age-matched females with no history of cancer (other than non-melanoma skin cancer) may be selected from the PRISM Study (IRB #18-002366 The Predicting Risk after Screening Mammogram (PRISM) Study) or the Mayo Clinic Breast Mammography practice.

Exclusion Criteria: 

  • Male biological sex or gender.
  • Pregnant females (insufficient #s, skewed estrogen levels).
  • Unwilling to travel to Mayo Clinic Rochester to provide the blood and urine samples.

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